QA Specialist IV position available at AstraZeneca Pharmaceuticals LP in Frederick, MD to be responsible for assuring the quality of commercial & clinical products manufactured at the facility. Req'ts: Masters deg or foreign equiv in Pharmaceutical Systems Mgmt, Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biochemistry or rel + 5 yrs of prog resp exp in job offd or rel. The employer will accept pre- or post-Master's deg exp. Must have 5 yrs of prog resp exp in the biopharmaceutical or pharmaceutical industry w/: FDA regulations including 21 CFR 210, 211, & 11; ICH guidelines; data integrity; cleaning validation; eqpmt calibration & qualification; QA Lot disposition & release; QA compliance, audit, & inspection; validation & quality control; flow of material, personnel & eqpmt with production modules; gap analysis; risk assessment; deviation mgmt system; electronic document mgmt system; recording, reporting, assessing, & reviewing critical alarm reports for clinical, commercial, & validation runs; SAP; & Quality Metric mgmt using various databases & MS applications. In the alt, the employer will accept a Bach's deg or for equiv in a stated field plus 7 yrs of exp. Any suitable combo of edu, training, or exp is acceptable. 6pm to 6am /12 hrs shift [2 dys on - 2 dys off /3 dys on
- 3 dys off]. EOE. To apply, go to http://www.astrazenecacareers.com Scroll down, click "Search jobs," enter "R-051306" as the "Keyword," & click "Search." No calls please.